Two Nonclinical Testing Laboratories Hit with Warning Letters

FDA today announced the issuance of warning letters to two Chinese nonclinical testing laboratories who provide third-party testing and validation services to device manufacturers for use in premarket submission to FDA.

Nonclinical laboratory studies are experiments “in which test articles are studied prospectively in test systems (such as animals, plants and microorganisms or subparts thereof) under laboratory conditions to determine their safety,” according to the press release.

The agency inspected Mid-Link Testing Company located in Tianjin China, and Sanitation & Environmental Technology Institute of SooChow University in Suzhou, China, earlier this year and found laboratory oversight failures and animal care violations. The cited issues, according to FDA, raise concerns about the quality and integrity of its lab-generated data.

The laboratory oversight issues found like “pervasive failures” with data management, quality assurance, staff training, and oversight including the failure to accurately record and verify key research data. Since the failures mean testing cannot establish assured quality, it could lead to the use of unreliable data in premarket device submissions.

FDA also recorded animal care violations, citing one company’s failure to provide adequate care for the animals and both firms providing inadequate identification and recording of the animals used in lab testing.

Earlier in 2024, the agency alerted medical device companies of concerns involving third-party testing labs and recommended careful review of any data from testing that the company itself did not perform. “While a device sponsor may use a third-party lab for nonclinical studies, doing so does not relieve the device sponsor of the responsibility to ensure the accuracy of data included in their regulatory submission,” according to FDA’s statement.

Going forward, FDA said it does not intend to authorize any premarket submissions that use necessary data generated from these testing facilities and will be evaluating any impact these findings have on past submissions.

“The medical device industry must be built and sustained on safety, effectiveness, and quality,” said Owen Faris, PhD, acting director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health, in the press release. “The FDA will take action to protect patients, consumers, and the medical device supply chain from quality failures and violative practices. We strenuously remind industry of their responsibility and accountability for all data included in their submissions, which are required to comply with federal law.”